Other safety alerts
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| Canada: Health Canada requests quarantine of products from IPCA Laboratories following falsification and manipulation of data issues |
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Health Canada has taken the precautionary step of asking IPCA Laboratories in India to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the US Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company. IPCA has not disputed the FDA findings with Health Canada. The FDA has not issued a recall of any of the affected products.
Health Canada estimates that this affects approximately 21 active pharmaceutical ingredients (APIs). The Department has also asked Canadian companies that import product containing APIs from the IPCA facilities to temporarily quarantine these products.
To date, there has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, like the FDA, Health Canada is not requesting a recall of products already on the market. If the situation changes, the Department will take immediate action and inform Canadians.
As part of a normal process, regulators around the world share information and inspection reports. Health Canada continues to work with other international regulatory partners, Canadian importers and IPCA to gather more information about the products involved.
The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share, and risk assessments. This process will likely take a few weeks to complete given the complexity of efforts. At this time, Health Canada do not expect that there will be an immediate impact on the availability of these products. The Department will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.
Health Canada has requested that the voluntary quarantine continue until the Department is satisfied that adequate measures are in place to confirm the quality of the products from these facilities and protect the health and safety of Canadians. The Department will continue to keep Canadians informed as information becomes available.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../41443a-eng.php
In Hong Kong, there are 12 registered pharmaceutical products which are manufactured by IPCA Laboratories in India, including 1 active pharmaceutical ingredient registered by Sunrise Trading Co. (Sunrise) namely Famotidine (IPCA Laboratories) (HK-46044); 3 products registered by U.S. Summit Co. Ltd. (U.S. Summit) namely Rapiclav-1G Tablets 875mg/125mg (HK-63094), Tenocard-100 Tablets 100mg (HK-62468) and Tenocard-50 Tablets 50mg (HK-62469); and 8 products registered by Swedish Trading Co. Ltd. (Swedish Trading) namely Lisoretic-20 Tablets (HK-62063), Lisoril-20 Tablets 20mg (HK-62150), Lisoril-S Tablets 5mg (HK-62151), Lisoril-10 Tablets 10mg (HK-62158), Losanorm-50 Tablets 50mg (HK-62485), Xtor-10 Tablets 10mg (HK-61658), Xtor-20 Tablets 20mg (HK-61919) and Azibact-250 Tablets 250mg (HK-62320).
According to U.S. Summit, all their 3 products are not marketed in Hong Kong; and according to Swedish Trading, only 3 products namely Xtor-10 Tablets 10mg (HK-61658), Xtor-20 Tablets 20mg (HK-61919) and Azibact-250 Tablets 250mg (HK-62320) are marketed and the remaining 5 products are not marketed in Hong Kong. In light of the Health Canada announcement, the Department of Health (DH) has requested Sunrise and Swedish Trading to quarantine the active pharmaceutical ingredient and the 3 products respectively; and should contact IPCA Laboratories to follow-up.
The DH has contacted Health Canada to inquire further details related to the incident and continues the investigation on local situation, and will keep vigilant on any further action taken against the products by other overseas regulatory authorities.
Ends/ Thursday, September 18, 2014
Issued at HKT 17:00
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